Code of Practice on Relations with the Pharmaceutical Industry

1.Introduction

1.1 The purpose of this Code is to support the Society’s work which is to advance the study and treatment of glaucoma through programmes of education, research and the development of best practice.

1.2 The importance of medicines in the treatment of the condition has meant that there has always been a close relationship between the Society and its members and the pharmaceutical and medical device industries (‘Industry’). As the practice of medicine is largely self-governing, members have a responsibility to ensure that their participation in such collaboration is not in conflict with their duties towards patients and society. In addition the Society can only fully achieve its aims if it maintains its reputation with the scientific and medical communities and the general public as an authoritative, objective and unbiased body whose activities and relationships are beyond reproach.

1.3 In dealings with Industry, other issues may arise between members and the industry where the parties’ respective rights and obligations may give rise to uncertainty and potential disagreement.

The following guidelines have been developed to assist members in determining a) when a relationship with industry is appropriate and b) in establishing standard practice in collaborations with a pharmaceutical company.

2.General Ethical Principles

2.1 The medical profession and Industry are important partners in the delivery of care to patients and the public. As medical professionals, members are expected to place patients’ health and welfare above financial and commercial gain. Industry is in turn expected to research and market its products in an ethical manner.

2.2 Members should always seek to avoid any conflict between the interests of their patients and their interactions with Industry and where they arise should always be resolved in favour of the patient.

2.3 Members should always maintain professional autonomy, independence and a commitment to the scientific method.

2.4 Members shall respect International and national law, guidelines and codes applicable to the practice of medicine generally and the practice of ophthalmology and the treatment of glaucoma in particular.

2.5 Members should be open and transparent to their patients and at meetings, presentations and in publications as to their relationships with Industry and any potential conflicts of interest.

3. Participation in Industry-Sponsored Research

3.1 The essential requirement for participation by members in such research is that they should satisfy themselves as far as is reasonably practicable that such Industry-sponsored research is ethically acceptable, scientifically valid and socially responsible.

3.2 Participation of members in Industry-sponsored research must always be subject to the prior approval of a properly-constituted independent ethics committee.

3.3 Such research shall be conducted both by the member in his capacity as investigator and the sponsoring company in accordance with applicable rules. These principally comprise the principles of the ICH Good Clinical Practice Guidelines (‘ICH GCP’), Council Directive 2001/9 on clinical trials (‘Directive’), applicable European and national laws, codes and guidance and any local research governance standards directly concerning the conduct of clinical research involving medicinal products or medical devices. Members shall also comply with rules applicable to clinical research such as laws relating to personal data.

3.4 A key issue in the conduct of clinical research is that patients should not participate unless they have given their full, informed and competent consent. Members therefore have an obligation to ensure that the patient is fully aware:

That the member’s concern for the patient’s welfare is not dependant on the patient participating in the study;

Of the likely advantages and disadvantages in participation and alternatives to participation as well as other related matters where disclosure contributes towards truly informed consent;

That the patient may withdraw at any time and may revert to the existing therapies (unless the member advises otherwise at the outset that this may not be possible)

3.5 Members shall comply with, and assist the sponsoring company in complying with, legislation, codes and guidance notes governing the processing of personal data and, as required by law, shall register with or notify the relevant authorities as to the relevant data they process.

3.6 Members should be prepared to disclose the remuneration they receive for participation on clinical research to those (such as the member’s employer) that have a legitimate interest in knowing it and to honour any obligations they have towards their employer or institution with which they are associated. Remuneration must be appropriate as judged by local standards and not constitute an enticement particularly to the extent that it might encourage members to recruit patients when it might not be in an individual patient’s best interests to participate.

3.7 Members should ensure that the sponsoring company indemnifies them and the institution to the extent which is generally acceptable locally for any loss or damage arising from the study except in circumstances where the member has been in negligent or in breach of contract or the research protocol.

3.8 Other issues which arise in concluding research contracts with a sponsoring company will obviously vary but the following are common practice:

Ownership of, or rights to, intellectual property: As a general rule the sponsor will normally claim all intellectual property rights where it has funded the research except where funding is provided as an unrestricted grant.

Freedom to publish: This can be a contentious issue but the company may commonly seek to restrict publication for commercial confidentiality and patent protection purposes or where the study is part of a multi-centre trial.

Termination: In addition to termination for breach of contract, the sponsoring company will normally reserve the right to terminate the contract at its discretion for medical, commercial or other reasons although the investigator will generally be reimbursed for all costs or expenses incurred or committed to before notice to terminate was given;

Law of the contract: The sponsoring company will generally agree to apply the law where the investigator is based particularly to facilitate the position of any patient who may claim under local clinical trial injury compensation laws or guidelines.

It is desirable that these and the other principal terms be clearly addressed in writing prior to the commencement of the research.

3.9 Where the study involves use of publicly-owned facilities, members will generally need to ensure that all costs are recovered from the sponsoring company.

4. Post-Marketing Surveillance Studies

4.1 Members may participate in surveillance studies (e.g. Phase IV post-marketing studies) where the studies are scientifically appropriate for the medicines or devices relevant to their area of practice. The extent of their participation should be consistent with generally accepted principles of ethical practice and research.

4.2 Members should seek to satisfy themselves that an apparent surveillance study is not a disguised promotional initiative on the part of the company concerned.

4.3 Members should consult with the Society and other available resources such as employers, review boards and independent ethics committees to assist them in deciding whether to participate in studies which they consider to be ‘borderline’.

4.4 The principles set out in 3.5 to 3.10 above apply equally to surveillance studies and should be similarly observed in this context. [Where the surveillance study involves a change from the treatment the patient would otherwise have received, members will likewise need to comply with the principles of 3.1 to 3.4 above].

5. Physician-Initiated Trials

5.1 Where a member wishes to initiate a study in relation to medicinal products or devices he will first need to be aware that this is likely to be at his own risk. This would be particularly important where the product concerned is not authorised or where an authorised product is being tested for an ‘off label’ use. Accordingly it should be confirmed that the question of insurance has been addressed. Requests for products from Industry for non-sponsored studies will normally only be fulfilled on the basis that the member acknowledges the foregoing issues.

5.2 The member will also need to satisfy himself as to his compliance with the rules such as are set out in 3.2 to 3.5 above.

6. Continuing Medical Education (‘CME’)

6.1 CME is designed to enhance the members’ ability to care for their patients. It is generally managed by accredited organisers who may receive financial and other assistance from supporting commercial and other organisations – including the Industry.

6.2 The planning, design, production and execution of CME events is the responsibility of the organiser. The organiser is also primarily responsible for managing the relationship with, and input from, the supporting company. Organisers of CME must not put themselves in a position where they find themselves with a conflict of interest.

6.3 CME support from Industry is appropriate provided that the contribution targets the educational needs of the audience rather than the promotional priorities of the sponsoring company.

6.4 Industry contributions should be by way of an educational grant made payable to the CME organiser for CME purposes.

6.5 Travel, accommodation and associated arrangements must be reasonable and must be secondary to the educational purpose of the CME event. Payment of reasonable honoraria and reimbursement for out-of -pocket expenses for speakers and presenters is customary and proper.

6.6 Members attending Industry-sponsored CME should not become involved in a promotional capacity e.g. ‘peer-selling’ thereby risking an apparently educational event being regarded as disguised promotion. Speakers should disclose any financial interest in the sponsor or the product.

6.7 The programme may acknowledge the sponsor’s contribution but not be overtly promotional. The data as presented in the CME materials should be as independent as possible and not overtly promotional. References to medicinal products, wherever possible, should be by means of the generic rather than the trade name. Presentation should be balanced. Offers of contributions from supporting companies reporting the results of scientific research should be accompanied by a detailed outline of the paper so as to allow the accredited organiser to verify its integrity. CME content documentation should disclose commercial support and commercial sponsorship should also be announced before the meeting and in post-meeting publications.

6.8 Negotiations for promotional displays at a CME event should not be influenced by Industry sponsorship of that event. No commercial promotional displays shall be displayed in the room during CME activities. Representatives of the supporting company may attend the event but may not engage in commercial activities while in the room where the CME takes place.

7. Industry Promotion

7.1 Members should not request gifts or other inducements from Industry for any purposes. Only gifts of modest value relevant to the practice of medicine should be accepted.

7.2 Members shall not accept extravagant or inappropriate hospitality from a company. Industry hospitality is appropriate where it is at a reasonable level judges against local standards, subordinate to the main purpose of the event and only afforded to a health professional.

7.3 A member may accept a scholarship, special funds or a travel grant from a company in order to attend medical conferences provided that it is relevant to his speciality, not conditional on past or anticipated prescribing habits and meets the criteria in 7.2 above. Payment by Industry of reasonable honoraria and expenses to speakers and presenters at such events is customary and proper.

7.4 Members may accept educational materials from the Industry where it is relevant to their area of practice.

7.5 Members may accept samples, up to the limit allowed by local law and guidance, in order to familiarise themselves with the product. They may not be associated with any form of gain for the member. Members are responsible for their age-related quality and security and the proper disposal of unused samples.

8.Consultancy and Investment

8.1 A member who is offered a consultancy (a contractual relationship whereby the member provides medical expertise to the company) may do so and he is entitled to reasonable remuneration for this role. Where attendance at medical events is part of his duties he is entitled to be paid his reasonable expenses for his accommodation, travel and meal expenses.

8.2 A consultancy with a company should not affect the treatment that a member provides to his patients.

8.3 A member, whether in his capacity as a consultant, conducting clinical research or otherwise, should not invest in a company to the extent that knowledge about the success of the company might inappropriately affect his prescribing behaviour nor should he expose himself to any situation which might reasonably amount to ‘insider dealing’.

9. Further Issues

This Code does not address issues of ownership and consent in relation to the use of tissues and organs and requirements as to declarations of interest.

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